For help on how to get the results you want, see our search tips.
235 results
Categories
Human Remove Human filter
-
List item
Summary of opinion: Pemazyre
pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Retsevmo
selpercatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Nexpovio
selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Sogroya
somapacitan, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Epidyolex
cannabidiol, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Evrysdi
risdiplam, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Jemperli
dostarlimab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
List item
Summary of opinion: Kalydeco (new)
ivacaftor, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
List item
Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
List item
Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
List item
Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
List item
Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy (new)
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
List item
Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis (new)
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders (new)
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia (new)
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021 -
List item
Orphan designation: Murine anti-CD22 antibody variable region fused to truncated Pseudomonas exotoxin 38 ( Moxetumomab pasudotox) for: Treatment of hairy cell leukaemia
Date of first decision: 05/12/2008, Positive, Last updated: 09/03/2021 -
List item
Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-polycythaemia vera myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021 -
List item
Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021 -
List item
Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of primary myelofibrosis
Date of first decision: 01/10/2010, Positive, Last updated: 03/03/2021 -
List item
Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major
Date of first decision: 29/07/2014, Positive, Last updated: 18/02/2021 -
List item
Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of myelodysplastic syndromes
Date of first decision: 22/08/2014, Positive, Last updated: 18/02/2021